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Study Will Assess the Safety, Neutralizing Activity and Efficacy of AZD3152 in Adults With Conditions Increasing Risk of Inadequate Protective Immune Response After Vaccination and Thus Are at High Risk of Developing Severe COVID-19 (NOVELLA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06057064
Recruitment Status : Active, not recruiting
First Posted : September 28, 2023
Last Update Posted : April 26, 2024
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:

AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.

The aim of the Phase II study is to evaluate the safety, neutralizing activity and efficacy of AZD3152 for pre exposure prophylaxis of COVID-19


Condition or disease Intervention/treatment Phase
COVID-19, SARS-CoV-2 Biological: Biological: AZD3152 Biological: Biological: Placebo Phase 2

Detailed Description:
Phase II study to assess the safety, neutralizing activity and efficacy of one dose of AZD3152 compared with one dose of placebo in adults with immunocompromised conditions, including comorbidities contributing to weakened immunity, thereby increasing the risk of COVID-19 progression up to severe grade.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase II Randomized, Double-blind Study to Evaluate the Safety, Neutralizing Activity and Efficacy of AZD3152 for Pre-exposure Prophylaxis of COVID-19 in adult participants. Approximately 116 participants in Russia will be randomized at up to 10 study sites in a ratio of 3:1 to either AZD3152 or placebo administered IM.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Double-blind Study to Evaluate the Safety, Neutralizing Activity and Efficacy of AZD3152 for Pre-exposure Prophylaxis of COVID-19 in Participants Having an Increased Risk for Inadequate Response to Active Immunization (NOVELLA)
Actual Study Start Date : September 29, 2023
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : May 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Single dose of Placebo IM (0.9% sodium chloride)
 Biological: Biological: Placebo
Single dose of Placebo IM (0.9% sodium chloride)
Experimental: AZD3152
Single dose of 300 mg IM
 Biological: Biological: AZD3152
300 mg single dose of AZD3152 IM


Outcome Measures
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Primary Outcome Measures :
  1. The number and proportion of subjects with AEs, SAEs, MAAEs, AESIs. [ Time Frame: up to Day 181 ]
    The safety profile will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data


Secondary Outcome Measures :
  1. Geometric mean titer (GMT) and geometric mean fold rise (GMFRs) [ Time Frame: up to Day 181 ]
    NAbs response will be evaluated based on nAbs titer to the SARS-CoV-2 emerging dominant variant(s) circulating during the course of the study

  2. incidence of a post-treatment symptomatic COVID-19 case [ Time Frame: up to Day 181 ]
    Incidence of a post-treatment symptomatic COVID-19 case (negative RT-PCR at baseline to positive RT-PCR or positive antigen test at any time up to 6 months AND symptoms specified in the modified WHO definition of symptomatic COVID-19).


Other Outcome Measures:
  1. The incidence of COVID-19 related hospitalization, and COVID-19 related death [ Time Frame: up to 181 Day ]

    The number and proportion of subjects diagnosed with COVID-19 with following events:

    • Composite number of COVID-19 related hospitalization and/or COVID-19 related death (WHO COVID-19 Clinical Progression Scale score ≥ 4)
    • Number of COVID-19 related hospitalization (separately)
    • Number of COVID-19 related death (separately)

  2. Incidence and percent of subjects with post treatment sero-response for SARS-CoV-2 nucleocapsid antibodies [ Time Frame: up to 181 Day ]
    Occurrence of post-treatment seroresponse (negative at baseline to positive at any time post-baseline up to 6 months) for SARS-CoV-2 nucleocapsid antibodies.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant must be 18 years of age or older at the time of signing the informed consent.
  • Weight ≥ 45 kg at Visit 1.

  • Participants must satisfy at least 1 of the following risk factors at enrollment:

    1. Obese, ie, BMI ≥ 30
    2. Congestive heart failure
    3. Chronic obstructive pulmonary disease
    4. Chronic kidney disease
    5. Intolerant of vaccine

    6. Immunocompromised state (one of the following risk factors ):

      1. Have cancer
      2. Have solid organ transplant or a hematopoietic stem cell transplant
      3. Are actively taking immunosuppressive medicines
      4. Received chimeric antigen receptor T-cell therapy
      5. Within 1 year of receiving B-cell depleting therapies
      6. Have a moderate or severe primary immunodeficiency
  • Medically stable
  • WOCBP must not be pregnant or lactating and must use a highly effective method of contraception

Exclusion Criteria:

  • Known hypersensitivity to any component of the study intervention
  • Previous hypersensitivity or severe adverse reaction following administration of a mAb
  • Acute or febrile infection prior to dosing
  • Has HIV infection
  • Receipt of any convalescent COVID-19 plasma treatment, mAb against SARS-CoV-2 , COVID-19 vaccine within 6 months
  • COVID-19 antiviral prophylaxis within at least 2 weeks
  • COVID-19 case within 6 months
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06057064


Locations
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Russian Federation
Research Site
Moscow, Russian Federation, 115478
Research Site
Moscow, Russian Federation, 115522
Research Site
Moscow, Russian Federation, 123182
Research Site
Moscow, Russian Federation, 125284
Research Site
Moscow, Russian Federation, 142770
Research Site
St Petersburg, Russian Federation, 197341
Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT06057064    
Other Study ID Numbers: AZ-RU-00002
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: April 26, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes,indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. All the data will be provided in blinded manner until final unblinded data analysis will be completed. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Pre-exposure Prophylaxis of COVID-19
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases